Devices and methods for performing procedures on a breast

ABSTRACT

A needle is used to mark a tissue area of interest. The needle may have one or more indicators which indicate selected angular orientations relative to the needle. The indicators may also be coupled to anchors which are deployed in the tissue to anchor the needle in the tissue. The needle may be positioned to guide an excisional device to remove tissue.

BACKGROUND OF THE INVENTION

The present invention pertains to the field of marking tissue areas ofinterest. In a specific application, the present invention relates tothe field of marking breast tissue for removal.

Breast cancer is a major threat and concern to women. Early detectionand treatment of suspicious or cancerous lesions in the breast has beenshown to improve long term survival of the patient. The trend is,therefore, to encourage women not only to perform monthly self-breastexamination and obtain a yearly breast examination by a qualifiedphysician, but also to undergo annual screening mammography commencingat age 40. Mammography is used to detect small, nonpalpable lesionswhich may appear opaque densities relative to normal breast parenchymaand fat or as clusters of microcalcifications.

The conventional method for diagnosing, localizing and excisingnonpalpable lesions detected by mammography generally involves atime-consuming, multi-step process. First, the patient goes to theradiology department where the radiologist finds and localizes thelesion either using mammography or ultrasound guidance. Once localized,a radio-opaque wire is inserted into the breast. The distal end of thewire may include a small hook or loop. Ideally, this is placed adjacentto the suspicious area to be biopsied. The patient is then transportedto the operating room.

Under general or local anesthesia, the surgeon may then perform aneedle-localized breast biopsy. In this procedure, the surgeon, guidedby the wire previously placed in the patient's breast, excises a mass oftissue around the distal end of the wire. The specimen is sent to theradiology department where a specimen radiograph is taken to confirmthat the suspicious lesion is contained within the excised specimen.Meanwhile, the surgeon, patient, anesthesiologist and operating roomstaff, wait in the operating room for confirmation of that fact from theradiologist before the operation is completed.

The suspicious lesion should then be excised in toto with a small marginor rim of normal breast tissue on all sides. Obtaining good margins ofnormal tissue using conventional techniques is extremely dependent uponthe skill and experience of the surgeon, and often an excessively largeamount of normal breast tissue is removed to ensure that the lesion islocated within the specimen. This increases the risk of post-operativecomplications, including bleeding and permanent breast deformity. As 80%of breast biopsies today are benign, many women unnecessarily sufferfrom permanent scarring and deformity from such benign breast biopsies.

More recently, less invasive techniques have been developed to sample orbiopsy the suspicious lesions to obtain a histological diagnosis. Thesimplest of the newer techniques is to attempt visualization of thelesion by external ultrasound. If seen by external ultrasound, thelesion can be biopsied while being continuously visualized. Thistechnique allows the physician to see the biopsy needle as it actuallyenters the lesion, thus ensuring that the correct area is sampled.Current sampling systems for use with external ultrasound guidanceinclude a fine needle aspirate, core needle biopsy or vacuum-assistedbiopsy devices.

Another conventional technique localizes the suspicious lesion usingstereotactic digital mammography. The patient is placed prone on aspecial table that includes a hole to allow the breast to dangletherethrough. The breast is compressed between two mammography plates,which stabilizes the breast to be biopsied and allows the digitalmammograms to be taken. At least two images are taken 30 degrees apartto obtain stereotactic views. The x, y and z coordinates targeting thelesion are calculated by a computer. The physician then aligns a specialmechanical stage mounted under the table that places the biopsy deviceinto the breast to obtain the sample or samples using fine needleaspiration, core needle biopsy, vacuum-assisted core needle biopsy orother suitable method. Fine needle aspiration uses a small gauge needle,usually 20 to 25 gauge, to aspirate a small sample of cells from thelesion or suspicious area. Core needle biopsy uses a larger size needle,usually 14 gauge to sample the lesion. Tissue architecture and histologyare preserved with this method. Multiple penetrations of the core needlethrough the breast and into the lesion are required to obtain anadequate sampling of the lesion. Over 10 samples have been recommendedby some. The vacuum-assisted breast biopsy system is a largersemi-automated side-cutting device. It is usually 11 gauge in diameterand is more sophisticated than the core needle biopsy device. Multiplelarge samples can be obtained from the lesion without having to reinsertthe needle each time. A vacuum is added to suck the tissue into thetrough. The rapid firing action of the spring-loaded core needle deviceis replaced with an oscillating outer cannula that cuts the breasttissue off in the trough. The physician controls the speed at which theouter cannula advances over the trough and can rotate the alignment ofthe trough in a clockwise fashion to obtain multiple samples.

If a fine needle aspirate, needle core biopsy or vacuum-assisted biopsyshows malignancy or a specific benign diagnosis of atypical hyperplasia,then the patient needs to undergo another procedure, the traditionalneedle-localized breast biopsy, to fully excise the area with anadequate margin of normal breast tissue. Sometimes the vacuum-assisteddevice removes the whole targeted lesion. If this occurs, a smalltitanium clip should be placed in the biopsy field. This clip marks thearea if a needle-localized breast biopsy is subsequently required forthe previously mentioned reasons.

Another method of biopsying the suspicious lesion utilizes a largeend-cutting core device measuring 0.5 cm to 2.0 cm in diameter. Thisalso uses the stereotactic table for stabilization and localization.After the lesion coordinates are calculated and local anesthesiainstilled, an incision large enough is permit entry of the bore is madeat the entry site with a scalpel. The breast tissue is cored down to andpast the lesion. Once the specimen is retrieved, the patient is turnedonto her back and the surgeon cauterizes bleeding vessels under directvision. The incision, measuring 0.5 to larger than 2.0 cm is suturedclosed.

The newer conventional minimally invasive breast biopsy devices haveimproved in some ways the ability to diagnose mammographically detectednonpalpable lesions. These devices give the patient a choice as to howshe wants the diagnosis to be made.

SUMMARY OF THE INVENTION

In a first aspect of the present invention, a needle is provided forperforming a procedure on a patient's breast. The needle has a proximalportion and a distal portion. The proximal portion is movable between arigid condition and a flexible condition which may be selected by theuser.

After introduction into the patient's breast, the proximal portion ismade flexible. As mentioned above, needles are often introduced into thepatient to mark an area of interest. The needle is introduced in oneroom of the hospital or clinic and the patient is then moved elsewhere,such as a surgical room, for a procedure. When moving the patientbetween these locations, a rigid needle protruding from the breast cancause obvious problems from inadvertent contact. The present inventionprovides the ability to provide a flexible proximal portion which isless susceptible to inadvertent bumping and is less obtrusive to thepatient and medical personnel. The needle may penetrate some of thetissue being removed or may penetrate only tissue which is not beingremoved. The needle may also be made rigid again before performing themedical procedure or the medical procedure may be carried out with theproximal portion flexible.

In another aspect of the present invention, the needle may also have oneor more indicators for indicating angular orientations relative to alongitudinal axis of the needle. The angular information may be used forany suitable procedure including removal of breast tissue. The indicatormay be coupled to an anchoring element which may be deployed at the sameangular position. The anchor may be any suitable element such as a wire.

In still another aspect of the present invention, a guide element, suchas the needle, guides a tissue removing device. The guide element mayprovide indications as to the area of the breast tissue to be removed.For example, the guide element may have depth markers or may have theindicators described above which mark angular positions. The guideelement may also constrain the cutting device with a longitudinal stopand one or more angular stops which prevent rotation beyond one or moreangular positions. When removing tissue, the cutting device may alsohave a collection element, such as a bag, which collects the severedtissue for removal.

These and other aspects of the present invention will become apparentfrom the following drawings and description.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a needle made in accordance with the present invention.

FIG. 2 is a cross-sectional view of the device along line I-I of FIG. 1.

FIG. 3 is a cross-sectional view of the device along line II-II of FIG.1.

FIG. 4 is a cross-sectional view of the device along line III-III ofFIG. 1.

FIG. 5 is an exploded view of the shaft and locking mechanism.

FIG. 6 shows the anchors.

FIG. 7 shows the flexible portion of the shaft.

FIG. 8 shows the locking mechanism.

FIG. 9 shows a tissue removing device.

FIG. 10 shows the needle introduced into a breast.

FIG. 11 shows a first anchor deployed within the breast.

FIG. 12 shows a second anchor deployed within the breast.

FIG. 13 shows a stiffener removed to provide a flexible proximal end.

FIG. 14 shows the flexible, proximal portion taped to the breast.

FIG. 15 shows a tissue removing device advanced over the needle and acutting element deployed.

FIG. 16 shows a void where the tissue removing device has removed thetissue area of interest.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to FIGS. 1 and 10-14, a needle 2 made in accordance with thepresent invention is shown. The needle 2 may be used to perform or helpperform any procedure anywhere in the body. As an example of one suchprocedure, the needle 2 may be used to mark the location of a tissuearea of interest such as a tissue area to be removed. In a specificexample, the needle 2 is used to mark breast tissue which is to beremoved (FIG. 12). The term “needle” as used herein shall mean anydevice having an elongate shaft. Of course, as with the exemplaryembodiment, the device 2 may have actuators, manipulators, ablationelements, RF, ultrasound, or other functionality without departing fromthe scope of the invention.

The needle 2 may be introduced in the breast in a rigid condition tofacilitate introduction and then changed to a more flexible condition.As mentioned above, conventional needles are often introduced into thepatient to mark a tissue area of interest such as a tissue area to beremoved. The needle is often introduced in one room of the hospital orclinic where the area of interest can be visualized during introduction.After the needle has been introduced, the procedure takes placeelsewhere such as in a surgical room. When moving the patient betweenthese locations, a rigid needle protruding from the breast can presentobvious problems with respect to inadvertent contact. The presentinvention provides the ability to make part of the needle 2 flexible sothat the flexible part of the needle 2 can be moved out of the way oreven taped to the patient (FIGS. 13 and 14). The needle 2 may or may notpenetrate the tissue being removed depending upon the particularprocedure performed. The flexible part of the needle 2 may provide otheradvantages as described below.

The needle 2 may be changed between the rigid and flexible conditionsusing any suitable structure such as a removable stiffener 4. Afterremoval of the stiffener 4, the rigid condition may be restored at alater time by simply replacing the stiffener 4. When using the needle 2to manipulate tissue being cut, it may be advantageous to maintain theflexible condition to apply tension at varying angles depending upon thearea being cut. This provides obvious advantages over conventional rigidneedles (see dotted-line position of FIG. 13). One such systempermanently anchors the needle to the tissue with wires fused to thetissue using RF energy. The rigid needle is then manipulated whilecutting and removing tissue around the needle and wires.

Referring to FIGS. 9 and 15, the needle 2 may also be used to guideanother medical device such as a tissue cutting device 6. Any suitabletissue cutting device may be used and one of particular device interestis disclosed in U.S. Pat. Nos. 6,440,147 and 6,022,362 which are herebyincorporated by reference. The tissue cutting device 6 has a cuttingelement 8 movable between collapsed and bowed positions. The tissuecutting device 6 is pivoted or rotated so that the cutting element 8sweeps through and cuts the tissue along an arc. A tissue collectionelement 10 may also be provided which collects the tissue being cut.

Referring now to FIGS. 1, 5, 6 and 10, the needle 2 may have anindicator 14 to mark an angular position relative to the longitudinalaxis 16 of the needle 2. The indicator 14 extends radially outward fromthe needle at a angle selected by the user. The indicator 14 may alsosimply be a longitudinal stripe 18 or other marking on the shaft whichindicates a particular angular orientation on the needle 2. Theindicator 14 may provide information to the user regarding variousparameters depending upon the procedure being performed. For example,when using the device 6 described above, the angular position, orpositions, provide the user with the angular extent of the tissue to beremoved.

The indicators 14 may be coupled to one more anchors 20 which aredeployed to anchor the needle 2. The anchor 20 is preferably curved,such as J- or C-shaped, and extends radially to lie within the sameangular orientation as the indicator 14. An advantage of coupling theindicator 14 to the anchor 20 is that anchor 20 itself providesinformation regarding the relative orientation or the needle 2, anchor20 and tissue area of interest Thus, the anchor 20 itself may be one ofthe indicators 14. Although the anchor 20 and indicator 14 arepreferably aligned at the same angular orientation, they may also beoffset to account for the geometry of other devices used with the needle2. As can be appreciated, of course, the indicators 14 may also beindependent of any anchoring elements. For example, the needle 2 may beplaced in the breast and the indicators 14 could then be moved toselected angular position(s). The needle 2 may also have depth markers22 along the body. The anchor 20 is preferably a stainless steel wirehaving a sharpened tip to pierce through the tissue. The orientation ofthe anchor 20 is partially guided by the geometry of the arc-shapedlumens receiving the anchors 20 (FIGS. 2 and 3).

As can be appreciated, the various aspects of the present invention maybe practiced using many different physical configurations withoutdeparting from the scope of the invention. Thus, the following preferredembodiment is not intended to limit the scope of the invention.Referring to FIGS. 1-8, the needle 2 has a shaft 30 having a rigid tube32 coupled to a flexible tube 34. The rigid tube 32 has a sharp tip 37to pierce tissue. The rigid tube 32 is preferably a hypotube ofstainless steel having a size of 18 GA to 12 GA such as 16 GA. The rigidtube 32 has two openings 35, 36 or slots at or near the distal endthrough which the anchors 20 extend. The first opening 35 is radiallysmaller than the second 36 since the anchor 20 is deployed at apredetermined angular orientation aligned with the longitudinal markeror stripe 18. Of course, the needle 2 may be configured with bothanchors 20 rotatable or pivotable within the openings 35, 36. The tube32 also has a stop 38 which prevents further longitudinal movement ofthe tissue cutting device 6 and markers 40 for providing depthinformation.

Referring to FIGS. 1-8, the flexible tube 34 may be a three-lumenextrusion. The first and second lumens 42, 44 each receive one of theanchors 20 and the third lumen 46 receives the stiffener 4. The flexibletube 34 is bonded to the rigid tube 32 in any suitable manner such aswith an adhesive. The flexible tube 34 is sized to fit within the rigidtube 32. A portion of the side wall around the stiffener 4 is removed toform a cut-out 48 having a shoulder 50 to lock the stiffener 4 as nowdescribed

Referring to FIGS. 1, 5, 7 and 8, the stiffener 4 is shown. Of course,any type of stiffening device may be used. An actuator 52, which maysimply be an elongate rod, is advanced to expand and open first andsecond prongs 54, 56 at the distal end of the stiffener 4. The firstprong 54 has a shoulder 58 which engages the shoulder 50 formed by thecut-out 48 portion of the tube 34. Alternatively, the shoulder 50 may,of course, also be formed by the rigid tube 32 or a piece of materialattached to inner surface of the rigid tube 32. When the actuator 52 iswithdrawn, the prongs 54, 56 naturally collapses so that the shoulders50, 58 do not engage and the stiffener may be removed. FIG. 14 shows theproximal portion taped to the patient after removing the stiffener 4.FIG. 13 also shows the flexible portion being tensioned in differentdirections.

Use of the device is now described in connection with a tissue removalprocedure with reference to FIGS. 1 and 9-16. Of course, otherprocedures may be performed without departing from the scope of theinvention. The needle 2 is introduced into the area of interest undersuitable visualization such as ultrasound. Once the needle 2 has beenintroduced in a desired or known orientation relative to the tissue areaof interest, the entire needle 2 is rotated so that the first indicator14 and marker 18 are aligned with a first angular position relative tothe tissue area of interest. The first anchor 20 is then deployed intothe tissue with the anchor 20 deployed at the selected angularorientation. The second indicator 14 is then rotated to a secondselected angular orientation with respect to the area of interest. Thesecond orientation is determined by visualizing the area of interestrelative to the needle 2 and/or first anchor 20 to determine theappropriate location for the second anchor 20. The second anchor 20 isthen deployed by advancing the anchor into the tissue. As can beappreciated, the needle 2 and anchors 20 themselves provide visuallandmarks for locating the area of interest. The markings on the needle2 and the indicators 14 also help to guide use of the tissue cuttingdevice 6 as described herein.

The stiffener 4 is then removed to provide the flexible proximalportion. The flexible proximal portion may be taped to the patient toprevent inadvertent contact as shown in FIG. 14. When performing theprocedure, the flexible condition may be maintained to provide thebenefit described above such as the ability to pull from varying anglesas compared to a conventional rigid needle. The tissue removal device 6may then be coupled to the needle 2 as shown in FIG. 15 and thenadvanced while being guided by the needle 2. The needle 2 may beintroduced to a predetermined depth where the longitudinal stop 38guides the depth of introduction of the tissue removal device. Ofcourse, the needle 2 may be introduced deeper into the tissue with theuser using the depth markings 40 on the needle 2 and/or tissue removaldevice 6 to determine the appropriate introduction depth for the tissueremoval device 6. The cutting element 8 is then deployed to the bowedposition and the cutting element 8 is swept through tissue to cut aroundthe tissue area of interest. The tissue is then collected by thecollection element 10 for removal. The device 6 is then withdrawn andthe anchors 30 are retracted to permit withdrawal of the needle 2 aswell.

As can be appreciated, the present invention can be practiced in manydifferent forms and for many different procedures. Furthermore, theaspects of the invention are distinct. For example, the presentinvention provides a flexible proximal portion which is distinct fromthe ability to mark angular orientations. Thus, each feature of thepresent invention are independent of one another. Finally, numerousphysical modifications may be made without departing from the scope ofthe invention. For example, the anchors may be spikes, an expandablemesh, prongs, or a helical screw and the cutting device may be a wirecage, a multiple-bladed cutter, or simply a scalpel without departingfrom numerous aspects of the invention.

1-23. (canceled)
 24. A method of positioning a needle in a patient'sbreast for a medical procedure, comprising the steps of: providing aneedle having at least one radially movable indicator for indicating aradial angular orientation when viewed along a longitudinal axis of theneedle, the needle having a distal portion and a proximal portion;positioning the distal portion in a patient's breast with the proximalportion remaining outside the breast, radially moving the indicator to aradial position which provides an indication of a selected radialangular orientation relative to the longitudinal axis; and performing amedical procedure using information from the selected angularorientation.
 25. The method of claim 24, wherein: the performing stepincludes the step of removing breast tissue.
 26. The method of claim 24,wherein: the moving step is carried out to move the indicator to aposition which angularly bounds a tissue area to be removed from thebreast.
 27. The method of claim 24, wherein: the moving step is carriedout by moving at least one anchoring element, the anchoring elementbeing displaced angularly with respect to the longitudinal axis duringthe moving step.
 28. The method of claim 24, wherein: the moving step iscarried out with the at least one anchoring element being a thin,elongate element which pierces the breast tissue.
 29. The method ofclaim 27, wherein: the moving step is carried out with the at least oneanchoring element being a wire.
 30. The method of claim 28, wherein: theproviding step is carried out with the needle having a shaft; and themoving step is carried out with the anchoring element extending througha slot in the shaft.
 31. The method of claim 24, wherein: the movingstep is carried out by selecting at least two different angularpositions when viewed along the longitudinal axis of the needle.
 32. Themethod of claim 24, wherein: the moving step is carried out at least twotimes to indicate two different angular orientations relative to thelongitudinal axis.
 33. A needle for introduction into a patient'sbreast, comprising: an elongate shaft having a longitudinal axis; and afirst indicator for indicating an angular orientation when viewed alongthe longitudinal axis of the shaft, the first indicator being radiallymovable by the user to a selected radial angular orientation relative tothe longitudinal axis of the shaft.
 34. The needle of claim 33, wherein:the first indicator is moved to a position to provide angularinformation regarding a tissue area to be removed from the breast. 35.The needle of claim 33, wherein: the first indicator is coupled to ananchoring element, the anchoring element being displaced angularly withrespect to the longitudinal axis when the first indicator is moved bythe user.
 36. The needle of claim 35, wherein: the anchoring element isa thin, elongate element which pierces the breast tissue.
 37. The needleof claim 35, wherein: the anchoring element is a wire.
 38. The needle ofclaim 37, wherein: the wire extending through a slot in the shaft. 39.The needle of claim 33, further comprising: a second indicator forindicating another angular orientation when viewed along thelongitudinal axis of the shaft.
 40. A method of excising breast tissue,comprising the steps of: providing a guide element and a cutting device,the guide element having at least one radially movable indicator forindicating a radial angular orientation with respect to a longitudinalaxis of the guide element, the cutting device having a deployablecutting element mounted on a shaft; introducing the guide element into apatient's breast; advancing the cutting device into the patient'sbreast, the cutting device being slidably coupled to the guide elementso that the guide element guides the cutting device as the cuttingdevice is advanced into the patient's breast; deploying a cuttingelement on the cutting device after the advancing step; rotating theshaft so that the cutting element severs breast tissue; and removing thebreast tissue which has been severed by the cutting element.
 41. Themethod of claim 40, wherein: the rotating step is carried out with theshaft rotating less than 180 degrees relative to the guide element. 42.The method of claim 40, wherein: the providing step is carried out withthe guide element being a needle.
 43. (canceled)
 44. The method of claim40, wherein: the rotating step is carried out using the angularorientation indicated by the at least one indicator.
 45. The method ofclaim 40, wherein: the rotating step is carried out with at least twoangular orientations indicated on the guide element at least one ofwhich being selected by the user.
 46. The method of claim 40, wherein:the removing step is carried out with the severed breast tissue beingcontained in a collection element carried by the cutting device.
 47. Themethod of claim 46, wherein: the removing step is carried out with thecollection element surrounding and isolating the severed tissue from thesurrounding tissue.
 48. A system for removing breast tissue, comprising:a guide element the guide element having a first radially movableindicator for indicating an annular orientation with respect to alongitudinal axis of the guide element; and a cutting device, thecutting device having a deployable cutting element mounted on a shaft,the cutting device being configured to be slidably coupled to the guideelement.
 49. The system of claim 48, wherein: the guide element is aneedle.
 50. The system of claim 48, wherein: the guide element has afirst indicator for indicating an angular orientation with respect to alongitudinal axis of the guide element.
 51. The system of claim 50,wherein: the guide element has a second indicator for indicating anangular orientation with respect to the longitudinal axis of the guideelement.
 52. The system of claim 48, wherein: the cutting element beingdeployed by bowing an elongate cutting element, the cutting elementbeing coupled to a source of RF energy.
 53. The system of claim 52,further comprising: a tissue collection element carried by the cuttingdevice, the tissue collection element surrounding the severed tissue.54. The system of claim 53, wherein: the collection element is a bagwhich surrounds the severed tissue.